Uncut sheet for Testosterone TES Rapid test

The Testosterone (TES) Rapid Test Device (the “Uncut Sheet” format for manufacturing use) is a rapid immunochromatographic assay intended for the quantitative determination of testosterone concentration in human serum, plasma, or whole blood specimens.

This test is intended for in vitro diagnostic professional use and serves as an aid in the evaluation of testosterone deficiency or excess, including the diagnosis and management of conditions such as male hypogonadism, polycystic ovary syndrome (PCOS), and other androgen-related disorders

Testosterone measurement is clinically useful in the following contexts

1)Diagnosis of male hypogonadism (androgen deficiency) in men presenting with clinical signs and symptoms suggestive of testosterone deficiency

2)Evaluation of hyperandrogenic states in women, including hirsutism, acne, oligo-amenorrhea, and polycystic ovary syndrome (PCOS)

3)Assessment of ovarian and adrenal tumors, congenital adrenal hyperplasia, and other conditions causing testosterone excess or deficiency

4）Monitoring of anti-androgen and testosterone replacement therapy

The device provides quantitative screening results. The test results are intended for clinical reference only. Definitive diagnosis should be based on a comprehensive assessment of clinical presentation and other laboratory findings. Results should be interpreted in conjunction with patient history and other relevant clinical information. As testosterone levels follow a diurnal rhythm with peak levels in the morning, sampling time should be considered when interpreting results .

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.